Catheter Tray, Packaging System, and Associated Methods

ABSTRACT

A tray ( 100 ) for accommodating a coiled medical device, such as a catheter assembly ( 700 ), includes a first compartment ( 101 ), a second compartment ( 102 ), and a third compartment ( 103 ). The catheter assembly ( 700 ) and devices associated with a catheterization procedure, such as syringes ( 701,702 ) containing sterile water and lubricating jelly and a specimen container ( 703 ) can be disposed within the tray. Printed instructions ( 1001 ) can be included with the tray ( 100 ). When a CSR wrap ( 1000 ) is disposed about the tray ( 100 ), the printed instructions can be placed atop the CSR wrap ( 1000 ) but beneath an outer sterile wrap ( 1002 ). The printed instructions ( 1001 ) can include a patient portion ( 1202 ) that is detachably coupled to a health care services portion ( 1201 ) such that it can be taken home with the patient after the procedure.

CROSS REFERENCE TO PRIOR APPLICATIONS

This application claims priority and benefit under 35 U.S.C. §119(e)from U.S. Provisional Application No. 61/183,629, filed Jun. 3, 2009.This application is a continuation in part of, and therefore claimspriority to, U.S. patent application Ser. No. 12/495,148, filed Jun. 30,2009.

BACKGROUND

1. Technical Field

This invention relates generally to storage containers for medicaldevices, and more particularly to a storage container for a long,flexible medical implement, such as a catheter, and related medicaldevices, as well as an instruction manual included therewith.

2. Background Art

Medical devices, including surgical instruments, supplies, and so forth,are generally shipped from manufacturer to medical services provider insterile packaging. For example, a scalpel may be shipped to a surgeon ina plastic, vacuum-sealed, sterile package. Similarly, bandages may beshipped in paper, plastic, or paper composite sterile wrappers. When themedical services provider is ready to use the medical supply, thesterile package is removed. The medical services provider then uses theobject in accordance with the procedure being performed.

While conventional packaging works well for objects having a generallyunchanging form factor, special considerations have to be taken intoconsideration for some medical supplies. By way of example, catheterassemblies and other flexible equipment is generally shipped in a coiledconfiguration. Once the sterile packaging is removed, the catheter mustbe uncoiled prior to use. Care must be taken in shipping, unwrapping,and using the catheter. For instance, if a catheter is inadvertentlybent, kinked, or otherwise damaged, it may no longer be suitable foruse. Compounding this issue, catheters are available in a variety oflengths ranging from 100 centimeters to over 250 centimeters.

Traditional catheters are packaged, for example, in individualpackaging. The catheter and card are then sealed in a sterile plasticwrap. These catheters are prone to damage in shipment, storage, and whenbeing unpacked, as the card and wrap provide little physical protection.

Some manufacturers have started shipping catheters and other similardevices in flat plastic trays. For example, U.S. Pat. No. 6,068,121 toMcGlinch teaches one such tray. The tray has several specificallycontoured loops such that one universal tray will accommodate severaldifferent sized catheters. Such packaging presents a problem, however,in that large amounts of storage space are taken with a universal tray,especially when a relatively short catheter is shipped therein.Additionally, when in use, these trays occupy large amounts of a medicalservice provider's sterile workspace or table, leaving little room forrelated components, such as lubricants, fluid bags, and so forth.

There is thus a need for an improved container for flexible medicaldevices or catheters that facilitates more effective and simplerdeployment of the device during a procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separate viewsand which together with the detailed description below are incorporatedin and form part of the specification, serve to further illustratevarious embodiments and to explain various principles and advantages allin accordance with the present invention.

FIG. 1 illustrates a top, front, right perspective view of oneembodiment of a tray for a catheter or similar assembly in accordancewith embodiments of the invention.

FIG. 2 illustrates a top, front, left perspective view of one embodimentof a tray for a catheter or similar assembly in accordance withembodiments of the invention.

FIG. 3 illustrates a top plan view of one embodiment of a tray for acatheter or similar assembly in accordance with embodiments of theinvention.

FIG. 4 illustrates a front elevation view of one embodiment of a trayfor a catheter or similar assembly in accordance with embodiments of theinvention.

FIG. 5 illustrates a cut-away, left elevation view of one embodiment ofa tray for a catheter or similar assembly in accordance with embodimentsof the invention.

FIG. 6 illustrates a bottom plan view of one embodiment of a tray for acatheter or similar assembly in accordance with embodiments of theinvention.

FIG. 7 illustrates a top, front, right perspective view of oneembodiment of a tray for a catheter or similar assembly, with a catheterand corresponding procedural devices disposed therein, in accordancewith embodiments of the invention.

FIG. 8 illustrates a top plan view of one embodiment of a tray for acatheter or similar assembly, with a catheter and correspondingprocedural devices disposed therein, in accordance with embodiments ofthe invention.

FIG. 9 illustrates a transparent, front elevation view of one embodimentof a tray for a catheter or similar assembly, with a catheter andcorresponding procedural devices disposed therein, in accordance withembodiments of the invention.

FIG. 10 illustrates a perspective view of one embodiment of a tray for acatheter or similar assembly, with a catheter and correspondingprocedural devices disposed therein, along with instructions andpackaging, in accordance with embodiments of the invention.

FIG. 11 illustrates a method of manufacturing one embodiment of a trayfor a catheter or similar assembly, with a catheter and correspondingprocedural devices disposed therein, in accordance with embodiments ofthe invention.

FIG. 12 illustrates one embodiment of printed instructions in accordancewith embodiments of the invention.

FIG. 13 illustrates one embodiment of printed instructions in accordancewith embodiments of the invention.

FIGS. 14-19 illustrate exemplary panels of printed instructions inaccordance with embodiments of the invention.

FIG. 20 illustrates a physical configuration of printed instructions inaccordance with one embodiment of the invention.

FIG. 21 illustrates a method in accordance with embodiments of theinvention.

Skilled artisans will appreciate that elements in the figures areillustrated for simplicity and clarity and have not necessarily beendrawn to scale. For example, the dimensions of some of the elements inthe figures may be exaggerated relative to other elements to help toimprove understanding of embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention are now described in detail. Referring tothe drawings, like numbers indicate like parts throughout the views. Asused in the description herein and throughout the claims, the followingterms take the meanings explicitly associated herein, unless the contextclearly dictates otherwise: the meaning of “a,” “an,” and “the” includesplural reference, the meaning of “in” includes “in” and “on.” Relationalterms such as first and second, top and bottom, and the like may be usedsolely to distinguish one entity or action from another entity or actionwithout necessarily requiring or implying any actual such relationshipor order between such entities or actions. Also, reference designatorsshown herein in parenthesis indicate components shown in a figure otherthan the one in discussion. For example, talking about a device (10)while discussing figure A would refer to an element, 10, shown in figureother than figure A.

Embodiments of the present invention provide a tray configured toaccommodate a coiled medical device such as a catheter or catheterassembly. In addition to accommodating the coiled medical device,embodiments of the present invention are also configured to containdevices and materials intended for use with the coiled medical device.

Using a catheter assembly as an example, when a catheter assembly isinserted into a patient, sterile water may be used to inflate thecatheter. Additionally, the catheter may be coated in a lubricatingjelly prior to insertion into the patient. Fluids and other samples maythen be monitored and obtained from the patient via the catheter.Embodiments of the present invention provide a single containerconfigured to accommodate not only the catheter assembly and fluid bag,but also syringes containing sterile water or lubricants. Further, thetray can accommodate a sterile specimen jar for capturing samples takenfrom the patient via the catheter.

In addition to simply accommodating these corresponding medical devices,in one embodiment the tray is configured to provide the medical servicesprovider with mnemonic devices instructing them in which order to useeach device. For example, a compartment containing syringes, in oneembodiment, includes an inclined, stair-stepped bottom member to presentthe plungers of each syringe at an easy to reach angle and at differentheights based upon order of use.

Another advantage of embodiments of the present invention is thatcompartments have multi-purpose functionality. For example, in oneembodiment, a container configured to accommodate a syringe havinglubricating jelly disposed therein is also configured to be used as alubricating jelly applicator. A medical services provider firstdispenses the lubricating jelly into the syringe compartment. Themedical services provider then passes the catheter from anothercompartment through an opening in a barrier separating the compartmentsinto the lubricating jelly. As such, the tray not only serves as ashipping and storage container for an assembly of devices used with acatheter procedure, but also as an application device to assist amedical services provider in using those products together.

Turning now to FIGS. 1-6, illustrated therein are views of oneembodiment of a tray 100 configured to accommodate a catheter assemblyin accordance with embodiments of the invention. FIG. 1 illustrates atop, front right perspective view of the tray 100. FIG. 2 illustrates atop, front, left perspective view of the tray 100. FIG. 3 illustrates atop plan view of the tray 100. FIG. 4 illustrates a front elevation viewof the tray 100. FIG. 5 illustrates a cut-away, left elevation view ofone embodiment of a tray 100. Likewise, FIG. 6 illustrates a bottom planview of the tray 100. For simplicity of discussion, these figures willbe referred to collectively with like reference numerals referring toidentical or functionally similar elements throughout the separateviews.

The tray 100, in one embodiment, is formed by a contoured surface 104that defines the various features and compartments of the tray 100. Thecontoured surface 104 of the tray 100 can be manufactured in variousways. For example, in one embodiment, the tray 100 can be thermallyformed on a mold from a soft thermoplastic, such as styrene orpolystyrene. In another embodiment, the tray 100 can be injectionmolded. In another embodiment, the tray can be poured on a mold using aquick setting plastic, epoxy, or resin. Other methods of manufacturewill be obvious to those of ordinary skill in the art having the benefitof this disclosure.

Exemplary dimensions for one embodiment of the tray 100 are as follows:The length 112 can be between nine and twelve inches, such as teninches. One illustrative length 112 may be 10.380 inches. Similarly, thewidth 113 can be between eight and eleven inches, such as nine inches.One illustrative width 113 is 9.250 inches. The height 114 can bebetween one and three inches. One illustrative height 114 is 1.750inches.

In one embodiment, the tray 100 includes three main compartments: afirst compartment 101, a second compartment 102, and a third compartment103. The first compartment 101 is separated from the second compartment102 by a first barrier 105. The second compartment 102 is separated fromthe third compartment 103 by a second barrier 106.

In one embodiment, the compartments are open from the top of the tray100—the top being opposite the base members of the tray 100—and arebounded on the bottom by a first base member 107, a second base member108, and a third base member 109. The compartments are bounded on thesides by a perimeter wall 110. In the illustrative “open top” embodimentof FIG. 1, the perimeter wall 110 ends in a horizontal flange 111extending substantially orthogonally from the perimeter wall 110. Itwill be clear to those of ordinary skill in the art having the benefitof this disclosure that embodiments other than that shown in FIG. 1 arepossible without departing from the spirit and scope of the invention.For instance, the top of the tray 100 could have a hinged orsnap-coupled lid that is opened or removed to reveal the compartmentsthere beneath.

In one illustrative embodiment, the tray 100 is configured to hold orotherwise accommodate all of the necessary devices and materials toperform a catheter-based procedure on a patient. Said differently, thetray 100 is configured to hold not only the catheter assembly, but themedical devices corresponding to catheter use as well. Using oneillustrative procedure as an example, the following devices will beused: a syringe holding sterile water, a syringe holding lubricatingjelly or another equivalent lubricant, a catheter assembly, skincleansing or preparation materials, and a specimen jar. The variouscompartments and features of the tray 100 shown in FIGS. 1-6 will bedescribed for use with these devices. As will be described in moredetail below, additional objects can be included with the tray, such asone or more towels, a drape to cover the patient, rubber gloves, handsanitizing materials, swab sticks, a securement device, a Foley inserttag, a printed instruction pamphlet, and so forth. The syringe holdingsterile water, syringe holding lubricating jelly, catheter assembly, andspecimen jar are used for illustration purposes only, as it will beclear that other objects may be added to or substituted for theseobjects. Further, subsets of these objects may be used.

In one embodiment suitable for procedures using the syringe holdingsterile water, syringe holding lubricating jelly, catheter assembly, andspecimen jar, in one embodiment, the tray 100 is configured such thatthese objects are ordered in accordance with their use during theprocedure. For example, in one embodiment the tray 100 includes a firstcompartment 101 for accommodating one or more syringes, a secondcompartment 102 for accommodating the catheter assembly, and a thirdcompartment 103 for accommodating the specimen jar. These devices stowedin the various compartments will be illustrated and described withrespect to FIGS. 7-10 below. The discussion of FIGS. 1-6 will includethe features of the tray 100 that make the tray 100 suitable foraccommodating these devices.

For example, in one embodiment the first compartment base member 107includes a stair-stepped contour 115 suitable for accommodating aplurality of syringes at different heights. For example, a first stepportion 116 of the stair-stepped contour 115 may be at a differentheight within the tray 100 than a second step portion 117 of thestair-stepped contour. In the illustrative embodiment of FIGS. 1-6, thefirst step portion 116—which is disposed farther from the first barrier105 than the second step portion 117—is shallower than the second stepportion 117. Said differently, the second step portion 117 is disposedat a greater depth within the tray 100 than the first step portion 116.

The stair-stepped contour 115 can be used as mnemonic device whenmultiple syringes are stored within the first compartment 101. Forexample, it may be intuitive that a syringe placed on a higher stepportion may need to be used first. This intuition is further enforcedwhen the higher step portion is disposed farther to the left in aleft-to-right usage configuration. Thus, a user receives a mnemonicreminder to use a syringe disposed on the first step portion 116 priorto a syringe disposed on the second step portion 117, as it is bothhigher and farther to the left.

Where syringes are stowed in the first compartment 101, the firstcompartment base member 107 can further be configured for syringe easeof use. For example, in one embodiment the first compartment base member107 is inclined relative to other compartment base members. In theillustrative embodiment of FIGS. 1-6, the second compartment base member108 and third compartment base member 109 are substantially coplanarwith each other. Further, the second compartment base member 108 andthird compartment base member 109 are generally flat in these views,although it will be clear to those of ordinary skill in the art havingthe benefit of this disclosure that contours could be incorporated intoone or both of these base members.

In this illustrative embodiment, however, the first compartment basemember 107 is configured to be inclined relative to one or both of thesecond compartment base member 108 and third compartment base member109. As such, the stair-stepped contour 115 forms a ramp upon whichsyringes may be placed so that the plunger of each syringe ispredisposed to project upward and out of the tray 100. Said differently,the stair-stepped contour 115 is configured such that the first stepportion 116 and the second step portion 117 are disposed in anon-parallel orientation relative to the second compartment base member108. This configuration makes it easier for a medical services providerto grasp the syringes and remove them from the tray 100.

The first compartment base member 107 may include other featuressuitable for accommodating one or more syringes as well. In oneembodiment, one or both of the first step portion 116 and second stepportion 117 include recesses 118,119 for accommodating a syringe flange.These recesses 118,119 generally function to prevent the syringes fromsliding lengthwise within the first compartment 101. Similarly, in oneembodiment one or both of the first step portion 116 and the second stepportion 117 include protrusions 120 that help to prevent the syringesfrom sliding laterally within the first compartment 101.

In one embodiment, one or both of the first barrier 105 and the secondbarrier 106 include openings disposed therein. In the illustrativeembodiment shown in FIGS. 1-6, the first barrier 105 includes a firstopening 121 between the first compartment 101 and the second compartment102. Similarly, the second barrier 106 includes a second opening 122between the second compartment 102 and the third compartment 103. Eachof these openings has an opening depth associated therewith. Similarly,each opening has an opening width associated therewith. In theillustrative embodiment of FIGS. 1-6, the first opening 121 is boundedby a first opening base member 129 and two inclined first opening sidemembers 127,128, while the second opening 122 is bounded by a secondopening base member 131, an inclined second opening side member 130, andthe perimeter wall 110.

While the opening depths can be the same, in one embodiment the openingdepths are different. For example, in the illustrative embodiments ofFIGS. 1-6, the first opening 121 has a first opening depth 123 that isless than the second opening depth 124 of the second opening 122.Similarly, in one embodiment the opening widths are different. Forexample, in the illustrative embodiments of FIGS. 1-6, the first opening121 has a first opening width 125 that is less than the second openingwidth 126 of the second opening 122. Such a disparity in opening depthsand widths, as well as the inclusion of inclined opening side members,provides an advantage in some applications.

For instance, in many catheter procedures a pair of syringes—such assyringes having a one-half inch diameter—fits easily into the firstcompartment 101 when the tray 100 is made with the illustrativedimensions set forth above. However, some procedures require one or moreof the syringes to be larger. For example, some syringes are larger indiameter. These larger syringes are capable of nesting within the firstopening 121 and second opening 122. The inclined opening side membersprevent the syringe from moving lengthwise, while the disparate openingheights present the plunger of the syringe to the medical servicesprovider for easy removal from the tray 100.

The stair-stepped contour 115, working in tandem with the first opening121, gives the tray additional advantages over prior art cathetercontainers. For instance, when the first compartment 101 has a firstcompartment base member 107 configured with a stair-stepped contour 115,the first compartment 101 can be used as a lubricant applicator for thecatheter.

Specifically, the medical services provider may dispense the lubricatingjelly along the second step portion 117. As the second step portion 117is lower in the tray 100 than the first step portion 116, the secondstep portion 117 serves as a channel in which the lubricating jelly mayspread. A medical services provider may then pass the catheter throughthe first opening 121, through the channel formed by the second stepportion 117, i.e., along the second step portion 117 through thedispensed lubricating jelly, and out the top of the tray 100 to thepatient. This feature of the tray 100 greatly eases the application oflubricating jelly to the catheter when compared to prior art solutions.In one embodiment, the tray 100 is packaged with printed instructionsshowing the medical services provider how to apply lubricating jelly inthis manner. The printed instructions will be described in more detailbelow with respect to FIGS. 12-23.

This particular feature highlights another advantage of the“compartmentalized” structure of various embodiments of the invention.As the tray 100 includes multiple compartments, various tasks associatedwith a catheterization procedure can be completed while keeping thecatheter within the tray 100. The ability to keep the catheter in thetray 100 reduces the risk that the catheter or corresponding deviceswill be contaminated with bacteria or microbes on other objects withinthe procedure room. For example, when the first compartment 101 is usedto apply lubricating jelly to the catheter, the lubricating jelly can beapplied while the catheter is contained within the tray 100, therebyreducing the risk that the catheter will become contaminated. Thiscorrespondingly reduces the risk of infection for the patient receivingthe catheter.

Prior art systems, for example such as those in which thecatheterization procedure components are shipped in separate containers,may contribute to substandard techniques in that the catheter can becomecontaminated when moving it from its shipping container. Consequently,the patient can be at an elevated risk of infection as the catheter ismoved from one tray to another. Embodiments of the present inventionsolve this problem by providing a single level tray 100 withcompartments. Further, in one embodiment the first compartment 101includes the first opening 121 so the catheter can stay in place duringand after lubrication. By having easy access to the components disposedin the single level tray 100, the medical services provider can moreeasily prepare and use the components within the tray 100. This helps tominimize the risk of contaminating the patient or the sterile fieldduring the procedure.

In one embodiment, the second step portion 117 is configured to beinclined at a shallower angle than the first step portion 116 in atleast a portion opposite the recess 119 from the first opening 121. Whenconfigured in such a fashion, the second step portion 117 includes a“cutdown” so that the catheter can stay within the channel both duringand after lubrication.

Additionally, the catheter can be placed in both the first opening 121and second opening 122 during lubrication. When positioned in thisconfiguration, the second opening 122 helps to align the catheter withthe first opening for easy passage through the lubrication channelformed by the second step portion 117.

The tray 100 of FIGS. 1-6 includes additional advantages over prior artcatheter packaging as well. For example, in one embodiment, instructions132 or other graphical indicia can be printed, placed upon, or moldedinto the horizontal flange 111. In one embodiment, compartmentdesignations can be placed above each compartment to ensure the medicalservices provider uses the correct device or material at the correcttime. In another embodiment, expiratory dates for materials or devicesdisposed within the tray 100 may be placed on the horizontal flange 111.It will be obvious to those of ordinary skill in the art having thebenefit of this disclosure that the invention is not so limited. Anynumber of various text or picture combinations can be printed on, placedupon, or molded into various parts of the tray. For instance, graphicalindicia can be applied to the compartment base members in addition tothe horizontal flange 111. Note that the horizontal flanges, in oneembodiment, can terminate in downwardly protruding vertical flanges forincreased stability during the printing process.

Another advantage of the tray 100 is that its compartmentalizedconfiguration helps to reduce the risk of contaminating a patient orcompromising the sterile nature of the components stored in the tray100. Since both the catheter assembly and medical devices correspondingto catheter use are stored within the same tray 100, the risk ofcross-contamination between sterile work areas and non-sterile spaces isminimized. Further, by having the catheter assembly and the devicescorresponding to catheter use stowed in a one-level tray rather than amulti-level, stacked configuration, the medical services provider canmore easily prepare and use the catheter and corresponding devicesdisposed within the tray 100.

Turning now to FIGS. 7-9, illustrated therein is a tray having acatheter assembly 700, syringes 701,702, and a specimen container 703stored therein as a catheter packaging system in accordance with oneembodiment of the invention. As with FIGS. 1-6, FIGS. 7-9 will bereferred to collectively with like reference numerals referring toidentical or functionally similar elements throughout the separateviews. FIG. 7 illustrates a top, front, right perspective view of thecatheter packaging system, while FIG. 8 illustrates a top plan view ofthe catheter packaging system. FIG. 9 illustrates a transparent, frontelevation view of the catheter packaging system.

The illustrative catheter packaging system of FIGS. 7-9 includes a tray100 having a first compartment 101, a second compartment 102, and athird compartment 103. In this illustrative embodiment, the firstcompartment 101 is configured to accommodate syringes 701,702. Thesecond compartment 102 is configured to accommodate a coiled medicaldevice, such as catheter assembly 700. The third compartment 103 isconfigured to accommodate the specimen container 703. The thirdcompartment 103 can accommodate other materials as well, including skinsanitizers and cleansing liquids, solutions, or gels, securement devicesfor securing the catheter to the patient, labels to affix to thecatheter for indicating the date the catheter was placed in the patient,and so forth. As mentioned above, additional devices corresponding tocatheter use, including towels, drapes, rubber gloves, and so forth, canbe disposed in the tray 100 as well. As an illustration of thisflexibility, a towel 704 is disposed beneath the catheter assembly 700.

As illustrated in FIGS. 1-6, each compartment of the tray 100 includes acompartment base member. Further, each compartment is separated by abarrier having an opening therein. A first barrier 105 having a firstopening 121 therein separates the first compartment 101 from the secondcompartment 102. Similarly, a second barrier 106 having a second opening122 therein separates the second compartment 102 from the thirdcompartment.

Syringes 701,702 are disposed in the first compartment, with one syringe701 being supported at a different elevation within the tray than theother syringe 702. The different elevations can be relative to eachsyringe 701,702, or to other components of the tray 100, such as thesecond compartment base member 108. Said differently, one syringe 701 issupported by the first compartment base member 107 at a shallower depthwithin the tray 100 than the depth of the second compartment base member108. Further, where the first compartment base member 107 is inclinedrelative to other base members, one or both syringes 701,702 will besupported in a non-parallel configuration relative to the secondcompartment base member 108. This is most readily seen in FIG. 9.

As noted above, some medical procedures will call for more materialsthan can be accommodated by a syringe capable of fitting within thefirst compartment 101. For such procedures, the tray 100 can be packedwith larger syringes. A large syringe (not shown) can be supportedlaterally within the tray 100 when it is placed across the tray 100 suchthat it lies within both the first opening 121 of the first barrier 105and the second opening 122 of the second barrier 106. Such a syringewill pass across the top of the catheter assembly 700, but will be heldin place by the side members of each opening.

Turning now to FIG. 10, illustrated therein is an exploded view of thetray 100 having the catheter assembly 700, a pair of syringes 701,702,and a specimen container 703 disposed therein. While only a specimencontainer 703 is shown as being disposed in the third compartment, notethat additional items could also be included within the thirdcompartment, including swab sticks, a catheter securement device, andtags or labels that may be affixed to other medical devices associatedwith the patient and in particular a urinary drain bag, wherein thelabel includes information regarding the catheter and it application tothe patient, such as a Foley insertion tag. Also, note that the pair ofsyringes 701,702 can be configured as shown in FIG. 10, or alternativelycan be both inserted in the first compartment, as described above. Inthe configuration of FIG. 10, rather than having both syringes 701,702disposed within the first compartment 101, one syringe 702 is disposedlaterally in the first opening 121 and the second opening 122 of thefirst barrier 105 and second barrier 106, respectively. Thisconfiguration is illustrative only.

Once the necessary components are disposed within the tray 100, the traycan be sealed with a CSR wrap 1000 to keep the internal componentssterile. In one embodiment, the CSR wrap 1000 is folded about the tray100 for sealing, and can be correspondingly unfolded to reveal the tray100. Once unfolded, the CSR wrap 1000 can then be used in the catheterinsertion process. For example, an unfolded CSR wrap 1000 can be used toprovide a sterile field in which the tray 100 sits for unloading andsubsequent use.

Printed instructions 1001 can then be attached or disposed upon orwithin the tray 100. In one embodiment, the printed instructions 1001include a health care services portion and a patient portion, as will beshown in FIGS. 12-13 below. The health care services portion can includeinstructions telling the health care services provider, for example, howto set up a sterile or otherwise clean work environment, how to preparethe catheter assembly 700 disposed within the tray, how to use the otherdevices within the tray, how to insert the catheter, how to secure thedrainage bag to the catheter, how to empty the drainage bag, how toobtain a urine sample, and so forth. The instructions can includepictures or illustrations showing visually how the various steps shouldbe done as well.

The patient portion can include helpful suggestions or instructions forthe patient. The patient portion can be detachably coupled to the healthcare services portion, such as by a perforated line that is easily tornto separate the patient portion from the health care services portion.In one embodiment, the patient portion, being attached to the healthcare services portion, serves as a reminder for the healthcare providerto give it to the patient. Examples of suggestions or instructions thatmay be included in the patient portion include information on what acatheter is, what the patient should understand about the catheter, howto reduce the chance of getting an infection, information aboutinfections commonly associated with catheters, symptoms of infectionscommonly associated with catheters, and suggestions for home use of thecatheter assembly 700. In one embodiment, the health care servicesportion may include an instruction for the health care services providerto detach the patient portion from the health care services portion andinstructions to discuss the patient portion with the patient. In oneembodiment, the patient portion may have a fill-in-able area for thehealthcare provided to write in the patient's name, physician's name andtelephone number and any other information appropriate to a patients andthere particular circumstance on already on the patient portion.

The health care services portion can tell the medical services providerhow to perform a standard catheterization procedure. For instance, inone embodiment, the tray 100 is equipped with an adhesive label that canbe used to identify the patient or specimen in the specimen container703. Further, a label can be included to mark or otherwise identify thematerial in the fluid bag attached to the catheter. Such labels caninclude pre-printed fields, such as date, time and name. Further theprinted instructions 1001 can notify the medical services provider thatthe devices disposed within the tray 100 are ordered corresponding touse during the catheterization procedure.

In another embodiment, the printed instructions 1001 can inform themedical services provider of special instructions. For instance, in oneembodiment the printed instructions 1001 can inform the medical servicesprovider not to leave a catheter in a patient for more than forty-eighthours without a physician's approval. Where the printed instructions1001 include such information, the labels included in the tray 100 mayhave pre-printed fields for the time of insertion that can be filled inby the medical services provider performing the catheterizationprocedure.

Once the printed instructions 1001 have been affixed to, or placed with,within, or atop the tray 100, the assembly can be sealed in a sterilewrap 1002 such as a thermally sealed bag. Inclusion of a sterile wrapallows the instructions to be included with the tray assembly, yetoutside the CSR wrap 1000. In this embodiment the sterile wrap 1002contains the tray, the instructions 1001, and the CSR wrap 1000. In oneembodiment the printed instructions 1001 are disposed atop the CSR wrap1000 such that the health care services portion of the printedinstructions 1001 is disposed on the top of the printed instructions1001, with the patient portion being disposed adjacent to the CSR wrap1000, such as when the printed instructions 1001 are configured as anaccordion-style folded instruction pamphlet. While the printedinstructions 1001 of one embodiment are configured as a folded, printed,separate article disposed atop the CSR wrap 1000, it will be clear tothose of ordinary skill in the art having the benefit of this disclosurethat the invention is not so limited. For example, in one embodiment thesterile wrap 1002 can be optional. In one embodiment, rather thanincluding separate printed instructions 1001, the instructions for usecan be printed on the CSR wrap 1000 as well. In one embodiment, thesterile wrap 1002 is transparent, allowing the printed instructions tobe read through the transparent material.

In yet another embodiment, the printed instructions are coupled to theoutside of the plastic sterilization pouch. The instructions may be inthe accordion style form or may be in a book style form. The book styleform may have a temporary adhesive to holds the book in a closedconfiguration until use, peeled open by the user.

Turning now to FIG. 11, illustrated therein is a method 1100 formanufacturing a packaged catheter assembly in accordance withembodiments of the invention. At step 1101, the manufacturer provides atray (100) having at least a first compartment (101) for accommodatingone or more syringes (701,702) and a second compartment (102) foraccommodating a flexible medical device, such as a catheter assembly(700). As noted above, in one embodiment the first compartment (101)will have a first compartment base member (107) having an inclined,stair-stepped contour (115). The first compartment (101) and secondcompartment (102) can be separated by a first barrier (105) having anopening (121) therein.

Once the tray (100) is procured, the manufacturer can dispose at leastone syringe (701) in the first compartment (101) at step 1102. In oneembodiment, as determined at decision 1104, a second syringe (702) willbe disposed in the first compartment (101) at step 1105. In anotherembodiment, the second syringe (702) will be disposed laterally withinthe first opening (121) and, where present, a second opening (122) atstep 1106.

At step 1103, the manufacturer will place the catheter assembly (700) inthe second compartment (102). Other components may be disposed in thetray (100) as well, including a specimen container (703) in a thirdcompartment (103) at step 1107, towels, drapes, printed instructions,and so forth.

At step 1108, the tray (100) is sealed. At optional step 1109, themanufacturer can enclose printed instructions (1001). In one embodiment,the printed instructions (1001) will direct a user to discharge contentsof at least one syringe into the first compartment (101) and to pass atleast a portion of the catheter assembly (700) through the opening andinto the contents to lubricate the catheter.

At step 1110, the manufacturer can place a sterile wrap about the tray(100) and the printed instructions (1001), where included. At step 1111,the completed assembly can be shipped to a medical services provider.

Turning now to FIGS. 12-13, illustrated therein is one embodiment of theprinted instructions 1001 in accordance with embodiments of theinvention. The printed instructions 1001 can be configured as aninstruction manual suitable for inclusion with a tray (100) as describedabove. FIG. 12 illustrates a view of a first side of the instructionmanual, while FIG. 13 illustrates a view of a second side of theinstruction manual.

In one embodiment, the printed instructions 1001 are configured as atwo-portion instruction manual having a health care services portion1201 and a patient portion 1202. In the illustrative embodiment of FIGS.12-13, the patient portion 1202 is detachably coupled to the health careservices portion 1201, and is thus separated from the health careservices portion 1201, by a perforation 1203. For example, where theprinted instructions 1001 are configured as a printed material on apaper-based stock, the perforation 1203 can be a perforated line runningalong a dimension of the printed instructions 1001 such that the printedinstructions 1001 can be easily torn along the perforation 1203 toseparate the patient portion 1202 from the health care services portion1201.

In one embodiment, the printed instructions 1001 are configured as aplurality of panels 1204,1205,1206,1301,1302,1303. As will be shown inFIG. 20, in one embodiment the printed instructions 1001 can beconfigured as an instruction manual that is formed with anaccordion-style fold, with each of the panels1204,1205,1206,1301,1302,1303 forming a page of the instruction manual.In the illustrative embodiment of FIGS. 12-13, panels 1204,1205 andpanels 1301,1302 form the health care services portion 1201, whilepanels 1206,1303 form the patient portion. Panels 1206,1303 areseparated from panels 1204,1205 and panels 1301,1302 by the perforation1203 such that the patient portion 1202 is tearably separable from thehealth care services portion 1201.

In one embodiment, the health care services portion 1201 includesinstructions 1304 for using the catheter assembly and othercorresponding medical devices disposed within the accompanying tray. Theinstructions 1304 can include text and/or figures or illustrationsshowing how to use the catheter assembly and corresponding medicaldevices on the patient, as well as instructions on preparation, takingsamples, preventing infection, and so forth. The instructions 1304, inone embodiment, also include an instruction to detach the patientportion 1202, give the patient portion 1202 to the patient, as well asan instruction to discuss the information disposed on the patientportion 1202 with the patient.

Similarly, the patient portion 1202 may also include instructions 1305and/or helpful suggestions for the patient who is undergoing thecatheterization procedure. For instance, this information can includeany one or more of the following: a description of what a catheter is,what the patient should know about the catheter, how to reduce thechance of getting an infection from the catheterization procedure, whatinfections commonly associated with catheterization procedures typicallyare, the symptoms associated with infections commonly associated withcatheterization procedures, and information about using the catheter athome. Additionally, the patient portion 1202 may include custominformation as well. For example, in one embodiment the patient portion1202 includes an informational section configured such that the healthcare service provider's name and contact information can be writtenthereon. It will be clear to those of ordinary skill in the art havingthe benefit of this disclosure that the invention is not so limited. Forexample, additional types of health care service instructions or patientinstructions or suggestions can also be included.

Turning now to FIGS. 14-19, illustrated therein are exemplary panels1204,1205,1206,1301,1302,1303. These panels1204,1205,1206,1301,1302,1303 are intended to illustrate exemplaryinstructions for the health care services portion (1201) and patientportion (1202) of an illustrative instruction manual for a catheterassembly and corresponding medical devices included with an accompanyingtray (100). It will be clear that these panels1204,1205,1206,1301,1302,1303 and the information printed thereon can bevaried in any number of ways without departing from the spirit and scopeof the invention as described herein and recited in the followingclaims. For example, the number of panels can be varied. Additionally,the information printed thereon can be condensed, expanded, or alteredwithout departing from the spirit and scope of the invention. Also, theexemplary information may be moved from the panels shown to otherpanels, as a particular application may warrant.

Beginning with FIG. 14, illustrated therein is one exemplary panel 1204.In one embodiment, panel 1204 will be configured such that when thecatheter package assembly within which the instruction manual isdisposed is initially opened, panel 1204 will be readily viewable. Forexample, where the catheter package assembly is assembled as shown inFIG. 10 above, once the sterile wrap (1002) is removed, the panel 1204will be viewable prior to removal of the CSR wrap (1000).

Panel 1204 can include general information about the catheter assemblyand corresponding medical devices disposed within the tray. For example,this information can include part number information 1401, trade nameinformation 1402, and manufacturer information 1403. A diagram 1404 ofthe contents of the package assembly may be included as well. Theillustrative diagram 1404 of FIG. 14 illustrates a tray 100 having acatheter assembly 700 and corresponding medical devices disposedtherein. The corresponding medical devices of this illustrativeembodiment include a pair of syringes 701,702 and a specimen container703. Additionally swab sticks 1408, a catheter securement deice 1409, aFoley insert tag 1410, vinyl gloves 1411, a fenestrated drape 1411, anunderbuttocks drape 1413, and a hand sanitizer 1414 solution or wipe aredisposed within the tray 100.

In addition to a diagram 1404, panel 1204 can also include a writtendescription 1407 of the elements included in the tray 100. Further,sterility information 1407 can be included. Panel 1204 can even includeinstructional material 1406 on how to use the instruction manual aswell.

Turning now to FIG. 15, illustrated therein is one embodiment of panel1301. As will be described below with respect to FIG. 20, in oneembodiment the printed instructions (1001) are configured as anaccordion-style folded instruction manual. In such a configuration,panel 1301 can be disposed on the back of panel 1204. Panel 1301 willtherefore be visible upon a health care services provider opening theinstruction manual.

Panel 1301 can include instructions for using the catheter assembly andthe corresponding medical devices. As can be seen from this illustrativeembodiment, panel 1301 can include instructions for setting up a cleanwork area. The instructions can include text, pictures, illustrations,or combinations of these.

In one embodiment, the instructions for setting up a clean work areainclude a hygiene performance step 1501, which may include instructionsto wash hands, optionally put on gloves (which at this step can benon-sterile gloves), and so froth. The instructions may then includeinformation on opening the remainder of the catheter package assembly.For instance, in FIG. 15 step 1502 indicates that the health careprovider should remove the CSR wrap (1000), which in this case is foldedabout the tray (100). Note that in this illustrative embodiment, as theCSR wrap (1000) is folded about the tray (100), removal of the CSR wrap(1000) by unfolding creates a sterile field about the tray (100).

Step 1503 then instructs the health care provide to pick up theunderbuttocks of the patient and to place the underbuttocks wrap beneaththe patient. Step 1504 then instructs the health care provider to usethe hand sanitizing solution provided with the catheter packageassembly.

As with other panels shown in FIGS. 14-19, the various panels mayinclude suggestions 1505 for preventing a catheter associated urinarytract infection. Some of this information is illustratively shown inFIG. 15. It will be understood that this information can be placed onone or more panels.

In addition to information for setting up a clean work area, in oneembodiment panel 1301 includes instructions for preparing the catheterassembly (700) as well. For example, step 1506 instructs the health careservices provider to don sterile gloves, as the hands were sanitized atstep 1504. Step 1507 tells the health care services provider to placethe fenestrated drape with a shiny side down on the patient withoutcontaminating the sterile gloves donned at step 1506. Step 1508instructs the health care services provider to test the balloon of thecatheter assembly with the water-filled syringe stored in the firstcompartment. Step 1508 also instructs the health care services providerto leave the syringe connected to the catheter assembly.

Step 1509 then provides instructions on using the first compartment ofthe tray as a lubricant application chamber as described above.Specifically, in this illustrative embodiment, step 1509 instructs thehealth care services provider to inject the lubricating jelly found inthe second syringe of the first compartment into the first compartment.Step 1509 also instructs the health care services provider to pass thetip of the catheter through the first opening in the wall separating thefirst compartment and second compartment into the lubricating jelly,thereby lubricating the tip of the catheter.

Turning now to FIG. 16, illustrated therein is an exemplary embodimentof panel 1302. The instructions printed thereon continue to provide thehealth care services provider with information regarding use of thecatheter assembly. For example, in one embodiment, this informationincludes instructions on inserting the catheter.

At step 1601, the instructions direct the health care services providerto tear open the swab stick package and to use the swab sticks to cleanthe patient from the top down. The instruction also notes that each swabstick is intended for one use only to properly maintain the sterilefield. Step 1602 directs the health care services provider to initiatethe catheterization process by inserting the catheter assembly into thepatient. Steps 1603 and 1604 continue this process as shown in FIG. 16.

Step 1605 directs the health care services provider to secure thedrainage bag to the catheter assembly. Step 1606 directs the health careservices provider to clean up upon completion of the catheterizationprocess. Step 1607 provides instructions on completing the label on theFoley insertion tag included with the catheter package assembly andattaching it to the tubing or drain bag attached to the catheterassembly.

At step 1608, the health care services provider is instructed to detachthe patient portion (1202) from the health care services portion (1201)by tearing the two apart along the perforation (1203). Step 1609 furtherinstructs the health care services provider to discuss the patientinformation printed upon the patient portion (1202) with the patient.Step 1609 instructs that documentation of the entire procedure should becompleted.

Turning now to FIG. 17, illustrate therein is one embodiment of panel1303, which represents a first side of the patient portion (1202). Thispanel 1303 includes information 1701 describing what a catheter is andwhy a catheter might be used. The panel 1303 also includes information1702 describing what the patient should know regarding catheters andcatheter use. For example, this information 1702 might notify thepatient that the health care services provider should wash hands priorto inserting the catheter, and that it is acceptable to ask them to doso if they have not done so before the patient.

The panel 1303 also includes information 1703 regarding how the patientcan reduce the chances of getting an infection. This information 1703can include a statement that the patient should wash their hands priorto touching the catheter assembly. The information 1703 may also includea statement that the drainage bag should always be kept at a levelbeneath the patient's navel, and that the patient should inform a helperwhen the bag is more than half full.

Turning to FIG. 18, illustrated therein is one embodiment of panel 1206.In this illustrative embodiment, panel 1206 forms the second side of thepatient portion (1202) of the instruction manual, and accordingly,includes additional information that a patient may wish to know whenusing a catheter assembly.

By way of example, information 1801 informs the patient as to whatcommon infections associated with catheter use are and how they arecontracted. Information 1802 provides symptoms of these commoninfections, such as fever, blood in the urine, burning or painfulurination, or frequent or more urgent urination after catheter removal.Information 1803 informs the patient of what they should know prior togoing home after a catheter procedure.

Information 1804 comprises an informational section configured such thata health care provider's name and contact information may be writtenthereon. This is helpful to the patient in the event that the symptomsrecited in information 1802 should arise after the procedure, in thatthe patient has readily available access to the information required tocontact a physician or other health care provider. An advantage ofhaving this information 1804 on the patient portion (1202) when thepatient portion (1202) is detachable is that the patient can take itwith them upon completion of the procedure.

Turning now to FIG. 19, which is a portion of the health care servicesportion (1201), illustrated therein is one embodiment of panel 1205 thatprovides additional health services information. For example,information 1901 for emptying the drain bag and information 1902describing how to obtain a urine sample can be included.

Turning now to FIG. 20, illustrated therein is one physicalconfiguration in which the printed instructions 1001 can be deliveredalong with the catheter package assembly in accordance with embodimentsof the invention. FIG. 20 is but one of many configurations, andembodiments of the invention are not to be limited in this respect, asFIG. 20 is illustrative only.

In FIG. 20, the printed instructions 1001 are configures as atri-section, accordion style bi-folded panel. Three sections2000,2001,2002 are folded in an accordion style, with two folds2003,2004 existing between the sections 2000,2001,2002. When the printedinstructions 1001 are configured as shown in FIGS. 12-13, folding theprinted instructions 1001 in this manner allows the health care servicesportion 1201 to be disposed atop the patient portion 1202. Further, whenthe printed instructions are disposed atop a CSR wrap (1000) as shown inFIG. 10, by disposing the patient portion 1202 adjacent to the CSR wrap(1000), the health care services provider removing the sterile wrap(1002) off of the catheter package assembly will be assured of seeingthe health care services portion 1201 first.

Turning now to FIG. 21, illustrated therein is a method 2100 of usingthe printed instructions (1001) as described herein. At step 2101, ahealth care services provider removes the sterile wrap (1002) disposedabout the catheter package assembly. Where the catheter package assemblyis configured as shown in FIG. 10, removal of the sterile wrap (1002)will reveal the printed instructions (1001). Where the printedinstructions (1001) are configured as described in FIG. 20, with thepatient portion (1202) disposed adjacent to the CSR wrap (1000), thehealth care services provider will see the health care services portion(1201) first.

At step 2102, the health care services provider accesses the printedinstructions (1001) and begins to read the panels, which in oneembodiment are panels configured in accordance with those described inFIGS. 14-19 above.

At step 2103, the health care services provider removes the CSR wrap(1000), which in one embodiment is then used to create a sterile fieldabout the tray (100). At step 2104, the health care services providerprepares the workspace, which in one embodiment may be in accordancewith steps (1501,1502,1503,1504) of panel (1301) in FIG. 15. At step2105, the health care services provider prepares the catheter, which inone embodiment may be in accordance with steps (1506,1507,1508,1509) ofpanel (1301) as described in FIG. 15.

At step 2106, the health care services provider inserts the catheter. Inone embodiment, this can be in accordance with steps(1601,1602,1603,1604) of panel (1302) as described in FIG. 16. At step2107, the health care provider secures the drain bag to the catheterassembly, which can be in accordance with steps (1605,1606,1607)described with respect to FIG. 16.

At step 2108, the health care services provider detaches the patientportion (1202) of the printed instructions (1001) from the health careservices portion (1201). In one embodiment, this occurs by tearing thepatient portion (1202) from the health care services portion (1201)along the perforation (1203), thereby transforming the printedinstructions (1001) or instruction manual from a singular or unitaryobject into a two-piece object consisting of the patient portion (1202)and the health care services portion (1201). As described, above, thehealth care services provider may then discuss the patient portion(1202) with the patient and further give the patient portion (1202) tothe patient to take home after the procedure.

In the foregoing specification, specific embodiments of the presentinvention have been described. However, one of ordinary skill in the artappreciates that various modifications and changes can be made withoutdeparting from the scope of the present invention as set forth in theclaims below. Thus, while preferred embodiments of the invention havebeen illustrated and described, it is clear that the invention is not solimited. Numerous modifications, changes, variations, substitutions, andequivalents will occur to those skilled in the art without departingfrom the spirit and scope of the present invention as defined by thefollowing claims. Accordingly, the specification and figures are to beregarded in an illustrative rather than a restrictive sense, and allsuch modifications are intended to be included within the scope ofpresent invention. The benefits, advantages, solutions to problems, andany element(s) that may cause any benefit, advantage, or solution tooccur or become more pronounced are not to be construed as a critical,required, or essential features or elements of any or all the claims.

1. An instruction manual configured for inclusion with a tray configuredto accommodate a catheter assembly and corresponding medical devices,the instruction manual comprising: a health care services portioncomprising instructions for using the catheter assembly and thecorresponding medical devices on a patient; and a patient portion,detachably coupled to the health care services portion and separatedfrom the health care services portion by a perforation.
 2. Theinstruction manual of claim 1, wherein the health care services portioncomprises instructions printed thereon for preparing the catheterassembly and for inserting the catheter assembly into the patient. 3.The instruction manual of claim 2, wherein the health care servicesportion comprises instructions printed thereon for preparing a catheterinsertion workspace and for securing a drain bag to a support.
 4. Theinstruction manual of claim 3, wherein the health care services portionfurther comprises instructions printed thereon for emptying the drainbag and instructions for obtaining a urine sample.
 5. The instructionmanual of claim 1, wherein the patient portion comprises instructionsprinted thereon for reducing a chance of contracting an infection fromusing the catheter assembly.
 6. The instruction manual of claim 5,wherein the patient portion comprises a description printed thereoncomprising symptoms of infections associated with use of catheterassemblies.
 7. The instruction manual of claim 6, wherein the patientportion comprises an informational section configured such that a healthcare provider's name and contact information may be written thereon. 8.The instruction manual of claim 1, wherein the instructions for usingthe catheter assembly and the corresponding medical devices on thepatient comprise illustrations showing how to use the catheter assemblyand the corresponding medical devices.
 9. The instruction manual ofclaim 1, wherein the instructions for using the catheter assembly andthe corresponding medical devices on the patient comprise an instructionto detach the patient portion and to give the patient portion to thepatient.
 10. The instruction manual of claim 9, wherein the instructionmanual is configured as a tri-section, accordion style bi-foldedpamphlet.
 11. A catheter package assembly with instructions, comprisinga tray having at least a first compartment having at least one syringedisposed therein and a second compartment having a catheter assemblydisposed therein, wherein the tray is sealed with a wrap; an instructionmanual comprising a health care services portion and a detachablycoupled a patient portion; and a thermally sealed bag disposed about thetray, wherein the instruction manual is disposed outside the wrap andwithin the thermally sealed bag.
 12. The catheter package assembly ofclaim 11, wherein the tray comprises: a contoured surface defining atleast three compartments separated by barriers and a perimeter wall, theat least three compartments comprising: the first compartment comprisinga first compartment base member having at least one stair-steppedcontour; the second compartment comprising a second base member; a firstbarrier separating the first compartment from the second compartment,wherein the first barrier defines a first opening between the firstcompartment and the second compartment, the first opening having a firstopening depth; a third compartment comprising a third base member; and asecond barrier separating the second compartment from the thirdcompartment, wherein the second barrier defines a second opening betweenthe second compartment and the third compartment, the second openinghaving a second opening depth.
 13. The catheter package assembly ofclaim 11, wherein the wrap comprises a CSR wrap.
 14. The catheterpackage assembly of claim 13, wherein the CSR wrap is folded about thetray.
 15. The catheter package assembly of claim 11, wherein theinstruction manual comprises a tearable perforation configured forseparating the health care services portion from the patient portion.16. The catheter package assembly of claim 11, wherein the instructionmanual is configured as a tri-section, accordion style bi-foldedpamphlet, with the health care services portion disposed atop thepatient portion such that the patient portion is disposed adjacent tothe wrap.
 17. The catheter package assembly of claim 16, wherein theinstructions comprise an instruction to detach the patient portion andto give the patient portion to a patient.
 18. The catheter packageassembly of claim 11, wherein the instruction manual comprisessuggestions for preventing infections corresponding to catheter use. 19.A method of using a catheter package assembly, comprising: opening athermally sealed bag disposed about a tray having a catheter assemblydisposed therein; accessing an instruction manual comprising a healthcare services portion and a patient portion detachably coupled thereto;removing a sealing wrap to reveal the catheter assembly; and detachingthe patient portion from the health care services portion, therebytransforming the instruction manual from a unitary object to a two-pieceobject.
 20. The method of claim 19, further comprising delivering thepatient portion to the patient.